The Real-world Study of AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
This is an observational study. All patients who meet the inclusion criteria of our previous Phase 2, open-label, single-arm study of neoadjuvant immune-checkpoint blockade therapy (AK104) combining with TACE for resectable hepatocellular carcinoma, but refuse to receive neoadjuvant treatment will be asked again to participate this observational study retrospectively and prospectively. Participants will receive surgery and regular monitoring for 1 year. The purpose is to provide real-world cohort for comparison with the neoadjuvant cohort.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years but ≤75 years
Resectable HCC staged BCLC A/B
Treatment naïve for HCC
Multiple tumor lesions
Disqualifiers
Any prior treatment for HCC.
Tumor rupture or bleeding. Suspected abdominal metastasis.
A major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to enrollment.
History of allogenic organ transplantation.
Trial population
Resectable HCC patients with high risk of recurrence
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Surgery with and without the aid of Indocyanine Green (ICG)
Procedure/SurgeryEnrolled patients will receive surgery and be follow up for 2 years
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: retrospective group1 intervention
Group B: prospective group1 intervention
Trial outcomes
Primary outcomes
1
1-year recurrence rate
1-year recurrence rate
Time frame
1-year recurrence rate2
1-year recurrence rate
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov